Eustachian Tube Growth and Development

Overview

This trial is active, not recruiting.

National Institute on Deafness and Other Communication Disorders (NIDCD)

Start date

August 2006

End date

July 2018

Trial size

150 participants

Trial identifier

NCT00422929, #0605009, 5P50DC007667-06

Summary

This study is to measure over time (from 3 years until 13 years of age) Eustachian tube
function (the way the Eustachian tube works) and facial growth in groups of children with
two types of middle-ear disease and with little past middle-ear disease. These measures will
be used to determine if facial growth is related to improved Eustachian tube function, to
see if the better function explains why young children who have middle-ear disease outgrow
it as they get older, and to determine if these measures are different for the children in
the three groups defined by disease history.

no history of significant otitis media (i.e., does not meet criteria for chronic OME or recurrent AOM)

Primary Outcomes

Measure

change in Eustachian tube function

time frame:
5 years

Secondary Outcomes

Measure

change in craniofacial measures

time frame:
5 years

Eligibility Criteria

Male or female participants from 3 years up to 3 years old.

Inclusion Criteria:
- 3 years of age
- History of middle ear disease must fit into one of the 3 categories of ear history
- With or without patent tympanostomy tubes at time of entry
- Generally good health
Exclusion Criteria:
- Cleft palate or other syndromes predisposing to otitis
- History of significant orthodontic treatment or plan for such
- Cholesteatoma or other past ear surgery other than tubes
- Unable to cooperate for testing

Additional Information

Official title

Eustachian Tube Growth and Development: Anatomy/Function

Principal investigator

William Doyle, PhD

Description

The existing literature documents an important role for the Eustachian tube (ET) in the
pathogenesis and/or persistence of otitis media (OM). Cross-sectional studies report a lower
prevalence of OM in older children, a better ET pressure-regulating function in older
children and age-related differences in ET form, length and width, and the vector
orientation of the paratubal musculature. These growth-related changes in ET structural
relationships are demonstrably predictive of increasingly more efficient ET function (ETF)
and, because the ET and paratubal musculature are intimately related to the cranial base,
the vector orientation of the ET system can be reconstructed from osteological or
radiographic data. Together, these observations suggest that measurable, age-related changes
in ET-paratubal muscle vector relationships are reflected in more efficient ETF and, by
consequence, a decreased OM risk. The overall goal of the proposed longitudinal study is to
evaluate the validity of this hypothesis.